Home Use IPL Beauty Device

K180016 · Shenzhen Mismon Technology Co., Ltd. · OHT · Mar 20, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180016
• Device Name: Home Use IPL Beauty Device
• Applicant: Shenzhen Mismon Technology Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Mar 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

Device Story

Personal light-based hair reduction device; utilizes Xenon flashlamp technology to deliver optical radiation to skin; models MELSYA-M5 and MS-206B; powered by external adapter; operated by end-user in home environment; user triggers pulses via finger switch; device provides direct illumination to tissue; energy density 5.5 J/cm²; intended to reduce unwanted hair; benefits include convenient at-home hair removal.

Clinical Evidence

No clinical efficacy trials performed. Evidence consists of bench testing: biocompatibility (ISO 10993-5, ISO 10993-10), electrical/photobiological safety (IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-57, IEC 62471), and a 20-participant OTC usability study confirming layperson understanding of device function and labeling.

Technological Characteristics

Xenon arc flashlamp energy source; direct tissue illumination; finger switch control; energy density 5.5 J/cm²; pulse duration 9-11 ms; spot sizes 3.9 cm² (MELSYA-M5) and 3.0 cm² (MS-206B); external power adapter; moderate level of concern software; biocompatibility per ISO 10993; electrical safety per IEC 60601 series.

Indications for Use

Indicated for removal of unwanted hair in small areas (underarm, facial hair below chin line) and large areas (legs) for over-the-counter use.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Perfectsmooth (K161428)
• iPulse SmoothSkin Gold Hair Removal System (K160968)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 20, 2018

Shenzhen Mismon Technology Co., Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road. S Shenzhen, 518000 Cn

Re: K180016

Trade/Device Name: Home Use IPL Beauty Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: OHT Dated: December 28, 2017 Received: January 2, 2018

Dear Rain Yip:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K180016

Device Name Home Use IPL Beauty Device

Indications for Use (Describe)

Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# "510(k) Summary" as required by 21 CFR Part 807.92.

## Date: 2017-12-28

#### I. Submitter

Shenzhen Mismon Technology Co., Ltd 2rd Floor, A2 Building, Zhengfeng Industrial Park, No.610 Fengtang Road, Fuyong Street, Bao'an District, Shenzhen, China

Tel.: [phone] Tax: [phone]

Vicky Yang General Manager Tel: [phone] Email: [e-mail]

## II. Device

Name of Device: Home Use IPL Beauty Device Common or Usual Name: Light Based Over-The-Counter Hair Removal Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810

# III. Predicate Device

The predicate devices are listed as below:

| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---------------------------------|-----------------------------------------------|---------------|----------------|
| Shen Zhen CosBeauty<br>Co., Ltd | Perfectsmooth | K161428 | March 23, 2017 |
| CyDen Limited | iPulse SmoothSkin Gold Hair<br>Removal System | K160968 | April 04, 2016 |

# IV. Device Description

The Home Use IPL Beauty Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL

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technology. Of which, the Device includes MELSYA-M5 and MS-206B two models. Both have adopted the same structure design, consisting of Hair removal device main body and power adapter two parts, and a hair removal lamp located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from power adapter via an external power.

The difference of MELSYA-M5 and MS-206B two models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of MELSYA-M5 is 3.9cm² and MS-206B is 3.0 cm², as well as the energy density of the both models is 5.5 J/cm2.

# V. Indications for Use

Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

# VI. Comparison of Technological Characteristics With the Predicate Device

The Home Use IPL Beauty Device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the Home Use IPL Beauty Device may be found substantially equivalent to its predicate device.

Home Use IPL Beauty Device is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

1) K161428, "PerfectSmooth", manufactured by "Shen CosBeauty Co., Ltd" in Guangdong, China

2) K160968, "iPulse SmoothSkin Gold Hair Removal System ", manufactured by "CyDen Limited" in Wales, UK

| Comparison<br>Elements | Subject Device | Predicate Device 1 | Predicate Device 2 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | Pending | K161428 | K160968 |
| Common name | Light Based Over-The-<br>Counter Hair Removal | Light Based Over-The-<br>Counter Hair Removal | Light Based Over-The-<br>Counter Hair Removal |
| Trade name | Home Use IPL Beauty<br>Device | PerfectSmooth | iPulse SmoothSkin<br>Gold Hair Removal<br>System |
| Comparison<br>Elements | Subject Device | Predicate Device 1 | Predicate Device 2 |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Pulse duration | 9-11 milliseconds | 11-13 milliseconds | 2-10 milliseconds |
| Energy density | 5.5 J/cm $^{2}$ | 4.7J/cm $^{2}$ | 3~6 J/cm $^{2}$ |
| Spot size | MELSYA-M5: 3.9cm $^{2}$<br>MS-206B: 3.0cm $^{2}$ | 4.5 cm $^{2}$ | 3 (3cm by 1cm) |
| Delivery device | Direct illumination to<br>tissue | Direct<br>illumination to<br>tissue | Direct<br>illumination to<br>tissue |
| Pulsing control | Finger switch | Finger switch | Finger switch |
| Indication<br>for<br>use/Intended use | Home Use IPL Beauty<br>Device is an over-the-<br>counter device intended<br>for removal of<br>unwanted hair such as<br>but not limited to small<br>areas such as underarm<br>and facial hair below<br>the chin line and large<br>areas such as legs. | The PerfectSmooth is<br>an over-the-counter<br>device intended for<br>removal of unwanted<br>hair such as but not<br>limited to small areas<br>such as underarm and<br>facial hair below the<br>chin line and large areas<br>such as legs. | The iPulse SmoothSkin<br>Gold Hair Removal<br>System is indicated for<br>the removal of<br>unwanted hair.<br>The iPulse Smoothskin Gold<br>is also indicated for the<br>permanent reduction in<br>hair regrowth, defined<br>as the long-term, stable<br>reduction in the number<br>of hairs regrowing<br>when measured at 6, 9<br>and 12 months after the<br>completion of a<br>treatment regime. |
| Location for use | OTC | OTC | OTC |

Information for predicate devices was obtained from publicly available sources, including the 510(k) Summary and device instruction manual.

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# VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

# 1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the Home Use IPL Beauty Device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk

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Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:

- > ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
- > ISO 10993-10:2010, Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization

# 2) Electrical Safety and Eye Safety

Electrical safety and Eye safety testing was performed to, and passed, the following standards:

- > IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- > IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- > IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- > IEC 60601-2-57 Medical electrical equipment -- Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

# 3) Eye Safety

- > IEC 62471 Photobiological safety of lamps and lamp systems
## 4) Software Verification and Validation

Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

## 5) OTC Usability Study

An OTC Usability Study was enrolled a total of 20 participant and was conducted to provide a basis for the Company to gather data from the layperson relative to level of labellings understanding of what the device is, what the device does and how it works. This Study was completed successfully and the results were no any issues or negative comments.

## Summary

Based on the above performance as documented in this application, Home Use IPL Beauty Device was found to have a safety and effectiveness profile that is similar to the predicate device.

#### VIII. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Home Use IPL Beauty Device is to be concluded substantial equivalent to its predicate devices.